Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2− Breast Cancer

Official Title

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

Summary:

Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2− breast cancer following recurrence or progression on or after AI therapy.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS) in the overall population

Secondary Outcome:

• PFS in PIK3CA/AKT1/PTEN-altered subgroup
• Overall Survival (OS)
• Investigator assessment of PFS2
• Response Rate (ORR)
• Duration of Response (DoR)
• Clinical Benefit Rate (CBR)
• ocurrence/frequency of AEs and its relationship to study drugs (safety and tolerability)
• plasma concentration of capivasertib
• EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module)
• The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items)
• Time to definitive deterioration of the ECOG (Eastern Cooperative Oncology Group) performance status

Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) breast cancer following recurrence or progression on or after aromatase inhibitor (AI) therapy.

View this trial on ClinicalTrials.gov